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Ocular MelanomaPhase 2DeCOGNCT01355120

THE IPI - Trial in Advanced Melanoma: Melanoma Patients With Advanced Disease

A Phase 2 study testing Ipilimumab in people with Ocular Melanoma, run by Prof. Dr. med. Dirk Schadendorf at 25 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an open-label, multi-center, single-arm clinical phase II study to further characterize the efficacy and safety of ipilimumab in patients with or without systemic pretreatment metastatic ocular melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ocular Melanoma
What is being tested?
Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
25 sitesGermany
Study dates
Oct 2011to Sep 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients meeting all of the following criteria will be considered for admission to the trial:
  • Histologically proven ocular melanoma
  • Measurable disease according to RECIST in unresectable stage III-IV
  • Minimum age of 18 years,
  • Able and willing to give valid written inform consent
  • Patients with or without prior systemic treatment for advanced malignant melanoma are eligible .
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  • In case of systemic pre-treatment, an interval of at least 28 days since treatment with chemotherapy, biochemotherapy, surgery, radiation, or immunotherapy is mandatory as well as recovery from any clinically significant toxicity experienced during treatment is recommended. Prior treatment must be completed by the time of ipilimumab administration. Palliative radiation therapy outside of the brain or therapeutic radiation to the brain after the patient's condition is stabilized and systemic steroids required for the management of symptoms due to brain metastases is decreased to the lowest fixed dose possible and does not require the 28-day waiting period. Patient must have recovered from any acute toxicity associated with prior therapy.
  • Expected survival of at least six months
  • ECOG Performance Status 0, 1 or 2.
  • Within the last 2 weeks prior to study day 1 the following laboratory parameters, which should be within the ranges specified:
  • Lab Parameter Range White blood cells (WBC) >= 2500/mm3 (≥ 1 2.5 x 109/L) Absolute neutrophil count (ANC) >= 1000/mm3 (≥ 1.0 x 109/L) Platelets ≥75.000/mm3 (≥ 75 x 109/L) Hemoglobin ≥ 9 g/dL (≥ 90 g/L; may be transfused) Creatinine <= 2.0 x ULN Bilirubin total <= 2.0 x ULN (excepted patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL) <= 5 x ULN for patients with liver metastases
  • No childbearing potential or negative pregnancy test of women of childbearing potential performed within 7 days prior to the start of treatment.
  • Women of childbearing potential (WOCP) must be using an effective method of contraception (Pearl-Index < 1, e.g. oral contraceptives, other hormonal contraceptives [vaginal products, skin patches, or implanted or injectable products], or mechanical products such as an intrauterine device or barrier methods [diaphragm, spermicides]) throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
  • No men of fathering potential or men of fathering potential must be using an effective method of contraception to avoid conception throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
  • WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal.
  • Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential.
  • WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) at Baseline within 7 days before the start of ipilimumab and at week 12.

Who cannot join

  • Patients will be excluded from the study for any of the following reasons:
  • The patient requires concomitant therapy with any of the following: IL 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; any other systemic therapy for cancer including any other experimental treatment.
  • The patient requires chronic use of systemic corticosteroids. Systemic steroids for management of symptoms due to brain mets should be avoided if possible or subject should be stable on the lowest clinically effective dose. Topical or inhalational steroids are permitted.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study treatment.
  • Active autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis).
  • Symptomatic CNS metastases (Remark: Asymptomatic stable, untreated or pretreated central nervous system (CNS) metastasis are allowed)
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  • Family history of congenital or hereditary immunodeficiency.
  • The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive or immunodeficient condition.
  • The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
  • Lack of availability for clinical follow-up assessments.
  • The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
  • Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders.
  • Patients with serious intercurrent illness, requiring hospitalization.
  • For female patients: the patient is pregnant or lactating. Women of childbearing potential: Refusal or inability to use effective means of contraception
  • Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
  • Subjects with melanoma who have another active, concurrent, malignant disease are not eligible for this trial, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix.
  • Previous treatment with ipilimumab

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Germany25 sites

  • Charité Universitätsmedizin Berlin, Campus Mitte

    Berlin, 10117

  • Krankenhaus Buxtehude

    Buxtehude, 21614

  • Universitätsklinik Köln

    Cologne, 50937

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • Universitätsklinikum Erlangen Hautklinik

    Erlangen, Bavaria, 91052

  • University Hospital Essen

    Essen, 45122

  • Klinikum der Johann Wolfgang Goethe Universität

    Frankfurt am Main, 60590

  • Universitätsklinikum Heidelberg Hautklinik

    Heidelberg, 69115

  • Universitätsklinikum des Saarlandes, Homburg

    Homburg/Saar, 66421

  • Klinik Universitätsklinikum Jena Klinik f. Hautkrankheiten

    Jena, 07743

  • Klinikum Kassel GmbH

    Kassel, Hesse, 34125

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Universitätsklinikum Leipzig Dermatologie

    Leipzig, 04103

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universitätsklinikum Klinik f.Dermatologie, Allegologie u.Venerologie

    Lübeck, Schleswig-Holstein, 23538

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Mannheim gGmbH, Medizinische Fakultät Mannheim derUniversität Heidelberg

    Mannheim, 68167

  • Johannes Wesling Klinikum Minden

    Minden, 32429

  • Ludwig-Maximilians-Universität München

    München, 80337

  • Fachklinik Hornheide

    Münster, 48157

  • Universitätsklinikum Münster Klinik u.Poliklinik f.Hautkrankheiten

    Münster

  • Klinikum Nürnberg Nord

    Nuremberg, Bavaria, 90419

  • Klinikum Dorothea Christiane Erxleben Quedlinburg gGmbH

    Quedlinburg, Saxony-Anhalt, 06484

  • Univ.-Klinikum Regensburg

    Regensburg, 93053

  • Universitätshautklinik Tuebingen

    Tübingen, 72076

Other trials in Germany

About this study

Official title: THE IPI - Multibasket Trial in Advanced Melanoma: Prospective Clinical Phase II Multibasket Study in Melanoma Patients With Advanced Disease (DeCOG MM-PAL11)

This is an open-label, multi-center, single-arm clinical phase II study to further characterize the efficacy and safety of ipilimumab in patients with or without systemic pretreatment metastatic ocular melanoma.

The DeCOG-MM-PAL11-Trial will be continued only for patients with ocular melanoma because sufficient numbers of cutaneous and mucosal melanoma patients have already been recruited. In order to allow the separate subgroup analysis as planned in the protocol for ocular melanoma it is mandatory to focus the recruitment to this patient population. Only this will guarantee a valid evaluation of all cohorts. Ocular melanoma is defined as melanomas originated from uvea, the choroid, the ciliary body and conjunctiva. (see McCartney ACE "Pathology of ocular melanomas" British Medical Bulltta, 1995, Vol 51, No 3 pp 678-693) The same criteria and treatment procedure as those used before will be applied for the patients with advanced ocular melanoma. Since no treatment standard in those patients does exist, also patients without prior systemic treatment can be included in this study. Therefore, the 5th inclusion criterion has been adapted in order to enrol the eligible patients.

Read the detailed description

Treatment:

Treatment with the anti-CTLA-4 mAb Ipilimumab monotherapy of each patient in the scope of this trial is defined as induction plus re-induction of eligible patients until 12 months after first receipt of study medication

Induction phase:

Ipilimumab will be applied to melanoma patients according to the protocol of the completed Medarex study MDX-010-20: Ipilimumab by IV infusion, 3 mg/kg, day 1 (Week 1), 22 (Week 4), 43 (Week 7), 64 (Week 10)

Re-induction:

Patients who progress following stable disease of ≥ 3 months duration starting from diagnosis at week 12 tumor assessment or patients who have progressed following an initial response (partial or complete) assessed at week 12 may be offered additional cycles of therapy with the originally assigned treatment regimen until off-treatment criteria are met, provided they meet re-treatment eligibility requirements. No patient will be re-treated if they experience a Grade 3 or higher gastrointestinal or certain other immune-related adverse events (irAE) (refer to section 5.2 and 5.3). No patient with disease progression following the first cycle of study medication will be permitted to be re-treated with study medication.

Examinations:

The disease will be assessed at baseline, after 12 weeks and for patients with stable disease or better responses, thereafter every 12 weeks in the absence of PD with a maximum of one year. Response evaluation will be done according to immune-related response criteria (Wolchok et al., CCR 2009).

All patients who prematurely discontinued treatment due to a drug-related adverse event prior to Week 12 (in the absence of disease progression) will return for all study visits and procedures including Week 12 and, if appropriate, further re-staging assessments. Any patient with documented progression at any scheduled re-staging visit and who will not receive any re-induction will undergo no further re-staging visits.

Follow-up phase:

Survival will be assessed every 3 months after the final dose of Ipilimumab until the end of the follow-up phase for the individual patient. FU phase for each subject is 1 year following first treatment dose. End of study will be at recruitment finished plus 1 year post start of treatment of last patient thus ensuring that 1 year survival rate can be estimated.

Study duration:

End of study is 1 year post LPFV. Recruiting period for the ocular melanoma:

Period of recruiting 12-18 months Enrolment start date (FPI): QIII 2011 Enrolment finish date (LPI): QI 2013 End of study: QI 2014

Conditions
Ocular Melanoma
Being tested
Ipilimumab
Keywords
advanced ocular melanoma
Medical subject headings
Uveal Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IpilimumabDrug

    Also called Yervoy

    Ipilimumab monotherapy 3mg/kg by four infusion every 3 weeks

Study groups in NCT01355120
Study groupRoleWhat they receive
a human immunoglobulinExperimentalFour infusions (i.v.) of 3mg/kg Ipilimumab in week 1, week 4, week 7 and week 10
Receives: Drug: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Overall survival rate at 12 months defined as the rate of patients alive 12 months after the date from the first study treatment for complete study

    Measured: alive 12 months after date from the first study drug adminstration

Secondary outcomes (8)

  1. safety and efficacy parameters

    The primary endpoint is the one-year survival rate. It is defined as the proportion of patients being alive 12 months after their first administration of the study treatment (ipilimumab).

    Measured: 12 months after date from the first study drug adminstration

  2. Efficacy according to immune-related response criteria (ir-RC) at any time during treatment

    Measured: 12 months after date from the first study drug administration

  3. Efficacy according RECIST criteria

    Measured: 12 months after date from the first study drug administration

  4. Progression free survival rate at 6 months

    Measured: 6 months after date from the first study drug administration

  5. Overall survival at 1 year in the subgroups (cutaneous, uveal, mucosal)

    Measured: 12 months after date from the first study drug administration

  6. To explore clinical efficacy of ipilimumab in relation to b-raf mutation status, brain metastases, LDH, HLA-A2 status

    Measured: 12 months after date from the first study drug administration

  7. To examine the value of peripheral blood absolute lymphocyte count (ALC) as a predictive biomarker in various patient cohorts with unresectable stage III-IV melanoma treated with ipilimumab monotherapy

    Measured: 12 weeks after date from the first study drug administration

  8. To evaluate possible surrogate markers in peripheral blood and tumour biopsy (translational research program)

    Measured: 12 weeks after date from the first study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionSep 2012
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01355120
Sponsor's protocol ID
DeCOG -MM-PAL11
Acronym
DeCOG
Status last verified
Jun 2014
First submitted
29 Dec 2010
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Zimmer L, Eigentler TK, Kiecker F, Simon J, Utikal J, Mohr P, Berking C, Kampgen E, Dippel E, Stadler R, Hauschild A, Fluck M, Terheyden P, Rompel R, Loquai C, Assi Z, Garbe C, Schadendorf D. Open-label, multicenter, single-arm phase II DeCOG-study of ipilimumab in pretreated patients with different subtypes of metastatic melanoma. J Transl Med. 2015 Nov 6;13:351. doi: 10.1186/s12967-015-0716-5.

    PubMed 26541511

  • Zimmer L, Vaubel J, Mohr P, Hauschild A, Utikal J, Simon J, Garbe C, Herbst R, Enk A, Kampgen E, Livingstone E, Bluhm L, Rompel R, Griewank KG, Fluck M, Schilling B, Schadendorf D. Phase II DeCOG-study of ipilimumab in pretreated and treatment-naive patients with metastatic uveal melanoma. PLoS One. 2015 Mar 11;10(3):e0118564. doi: 10.1371/journal.pone.0118564. eCollection 2015.

    PubMed 25761109

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ipilimumab in people with Ocular Melanoma, run by Prof. Dr. med. Dirk Schadendorf at 25 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: alive 12 months after date from the first study drug adminstration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01355120, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.

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